Senior Engineer – Risk Management

. Create and align global risk management processes to ensure consistent analysis of risks .

Posted 4/29/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $92,000 - $138,000 per yearWebsite

Key responsibilities & impact

Create and align global risk management processes to ensure consistent analysis of risks
Evaluate the risks and act as an approver for Change Controls, FMEA, MDR, Recalls, HHEs, and other quality events
Effectively communicate risks to senior global management
Build relationships with quality and business partners
Lead global cross-department collaboration to address risks with robust controls
Work with SMEs to create a framework for Risk-based dashboards
Provide detailed input to stakeholders on risk control implementation

What you’ll need

Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree
At least 4 years of QA/QE experience in a cGMP Device or environment
At least 2 years of direct risk management experience related to FDA regulated products
Experience creating quality sub-systems and leading complex projects
Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills

Comp & perks

ATS Keywords

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Hard Skills & Tools

risk managementFMEAMDRChange Controlsquality eventsrisk-based dashboardsQAQEcGMPproject management

Soft Skills

communicationrelationship buildingcollaborationprioritizationself-starteroral skillswriting skills